Cervicogenic Headache: A Case Report of Spinal Manipulative Therapy

Transcription

1 Cervicogenic Headache: A Case Report of Spinal Manipulative Therapy By: Don Ross Sanchez Doctoral Candidate University of New Mexico School of Medicine Division of Physical Therapy Class of 2014 Advisor: James Dexter, PT, MA Printed Name of Advisor: Signature: Date: Approved by the Division of Physical Therapy, School of Medicine, University of New Mexico in partial fulfillment of the requirements for the degree of Doctor of Physical Therapy.

2 Contents Abstract :... 4 Background/Purpose:... 4 Case Description... 4 Outcomes:... 5 Discussion :... 5 Section 1: Background and Purpose of the PICO question:... 6 Section 2: Case Description:... 7 Initial Evaluation (12/19/12):... 7 History:... 7 Work History:... 8 Prior Medical History:... 8 Exercise:... 8 Prior Level of Function:... 9 Pain Assessment:... 9 Posture:... 9 Cervical AROM: Special Tests:... 9 Joint Mobility: Functional Outcome Measure:.. 10 Assessment: Clinical Judgments and Problems List: Visit #2 (8/12/13) Visit #3 (8/19/13) Visit #4 (8/26/13) Visit #5 (9/23/13)

3 Visit #6 (10/7/13) Visit #7 (11/4/13) Visit #8 (11/18/13) Section 3: Evidence Based Analysis Discussion: Conclusion: References Appendix Appendix Appendix Appendix Appendix Appendix Appendix Appendix Appendix

4 Abstract Background and Purpose: Cervicogenic headache (CGH) is a secondary headache characterized by unilateral headache and symptoms and signs of neck involvement. It is often worsened by neck movement, sustained awkward head position or external pressure over the upper cervical or occipital region on the symptomatic side (Chaibi, 2012). The reported prevalence of CGH varies from 13.8% to 17.8% of the headache population in different epidemiological studies (Vavrek, 2010). CGH is difficult to treat because the etiology and pathophysiology are not well understood. Current physical therapy practice relies on a variety of modalities to treat patients with CGH, including spinal manipulative therapy (SMT). The current body of evidence has been aimed at determining the effectiveness of SMT for the management of CGH. The following case study seeks to answer the following PICO question: In adult patients with cervicogenic headache, how effective is cervical manipulation compared to other conservative treatment in controlling incidence, intensity, and duration of cervicogenic headache? Case Description This case study looked at a 34-year-old man diagnosed with head injuries and cervicalgia in 2013 with suspected onset 6 months prior from military active duty. Over the past 6 months, the patient had been experiencing sharp, unilateral headaches lasting from hours to days at a time. The patient was referred to physical therapy by his primary care physician for treatment of head injuries 4

5 (854.00) and cervicalgia (723.1). After physical examination, the physical therapist identified signs and symptoms consistent with cervicogenic headache. The following goals were set for the patient after his initial evaluation: 1. Patient will be independent with cervical exercises and postural correction. 2. Patient will increase pain free cervical AROM to WNL s 3. Patient will increase Patient Specific Functional Scale by 3-point average for sitting, standing, and exercise. Initial score: Patient will report decreased frequency of headache from 4-5x/week to >1x/week. Outcome The patient was able to meet all the goals except for goal 3, which was 90% met. The patient had good outcomes for decreasing frequency of headache and increasing AROM and functional rating. Discussion As a whole, the evidence for this PICO question was insufficient to offer evidencebased support for the application of SMT for CGH. Current research lacks methodological quality and fails to sufficiently report adverse events associated with SMT of the cervical spine. This case study was relevant because it showed the significance and importance of using evidence-based practice to guide clinical assessment of CGH and treatment. 5

6 Section 1: Background and Purpose of the PICO question Globally, the estimate of those with an active headache disorder is 46% of the adult population. According to a recent study by Stewart et al, headache is the most common pain condition causing loss of productive time the US work force Of all headaches, cervicogenic headache (CGH) accounts for 13-18% of the headache population (Vavrek, 2009). In CGH, pain is localized to the neck and occipital regions and may project to the forehead, orbital regions, vertex, or ears and special neck movements or sustained neck postures aggravate pain. (Goodman, 2009). Historically, CGH has been difficult to diagnose and treat because the etiology and pathophysiology are not well understood. Current treatment for CGH ranges from invasive surgeries to pharmaceutical intervention to conservative management with physical therapy, osteopaths and chiropractors. Among the interventions offered by the latter, spinal manipulative therapy (SMT) of the cervical and thoracic spine has emerged as a management approach for relief of pain, intensity and duration of CGH. Because CGH is a relatively new diagnosis, with its own set of diagnostic criteria, practitioners must weigh current research and consider anecdotal data along with patient beliefs and values when providing treatment. The patient in this clinical setting is a 34-year-old male who was diagnosed with head injury and carvicalgia in 2013 originating from active duty in The patient came to the clinic with complaints of sharp, unilateral headaches lasting from hours to days at a time accompanied by left shoulder pain. This patient presented with as a motivating case study with an interesting set of issues to address. This case study prompted the PICO question: 6

7 In adult patients with cervicogenic headache, how effective is cervical manipulation compared to other conservative treatment in controlling incidence, intensity, and duration of cervicogenic headache? Upon performing a literature review, research showed inconsistent and variable improvements for patients suffering from CGH when treated with SMT. Research also iterated the importance of improving the methodological quality of RCT s that are currently performed (Gross, 2010). Although there is not a single best approach for managing and treating CGH, the evidence suggests that a multimodal approach may be effective for relief of chronic symptoms (Carlesso, 2010). The outcomes of this case study are important for clinicians who see populations with CGH. Since current evidence does not supply sufficient data or methodological quality to confirm a best approach, case studies may assist in supplying anecdotal data for future studies to be based. It is important to have tools and strategies to treat these patients in particular as their condition is often debilitating and can result in loss of wages and productivity as well as impact the healthcare system in the form of costly, and often long term, medical interventions. Section 2: Case Description Initial Evaluation (08/05/13) History: The patient is a 34-year-old man who was referred to outpatient rehabilitation after having chronic headaches, neck and back pain, and shoulder pain. The patient s primary care physician referred the patient with the diagnosis codes of head 7

8 injuries (854.00) and cervicalgia (723.1). Patient reported initially begin experiencing headaches while serving in the military 2 years prior. The patient reported an insidious onset of symptoms but believes that carrying a rucksack on long marches led to the headaches and neck pain. Head injury was sustained in 2010 when patient fell off truck while loading supplies, patient reports no LOC from fall and no lasting impairments. The patient reported an increase in headache frequency and duration over the past 6 months averaging 3-4 headaches per week. The patient reported increased pain and shooting headache with certain head and neck positions, particularly when working in the computer at work or turning head to check traffic while driving. Patient reported no relief with over-thecounter medication and had no prior conservative treatment. Work history: Patient worked active duty for the military from as served as a truck driver. Duties performed ranged from vehicle maintenance, physical training, educational courses, and truck driving. Patient currently works full-time as an accountant for the Forest Service and spends the greater part of the day on a computer. Prior Medical History: Arthralgia, OCD, panic disorder, anxiety, irritable bowel syndrome, thyroid nodule, alcohol abuse, low back pain, HTN, asthma, lesions of ulnar nerve. Exercise: The patient uses elliptical machine and swims 2-3 times per week and uses weights 3 times a week. 8

9 Prior Level of Function: Independent in all aspects. Pain Assessment: Patient reports unilateral headache on R side with occasional L sided headaches as well. Pain is sharp and can last hours to days at a time. Pain is worse with increased head turning and with long durations of working on the computer. Patient tender to palpation to right upper trapezius, right scalenes, and right splenius capitis. Posture: Mild forward head posture with slightly excessive thoracic kyphosis. Cervical AROM: Left rotation: 45 deg Right rotation: 45 deg Left side bend: 23 deg Right side bend: 7 deg Flexion: 75% normal Extension: 50% normal Special Tests: (+) Compression (+) Distraction 9

10 (+) Quadrant Joint Mobility: AA hypermobility L>R Decreased mobility C2 R>L C3-5 stiffness L>R Functional Outcome Measure: Patient Specific Functional Scale: patient identified sitting, standing and exercising as the top 3 functionally limited activities. Score: 3.0 Note: Patient demonstrated no signs or symptoms of vertebral artery occlusion. Assessment: Diagnosis: the patient was referred with diagnoses of head injuries (854.00) and cervicalgia (723.1) Narrative Assessment: The patient s physical evaluation revealed impaired joint mobility and AROM of the cervical spine as well increased tenderness with palpation to the right cervical musculature. The patient s signs and symptoms are consistent with cervicogenic headache. Patient would benefit from skilled therapy intervention for increasing joint mobility and AROM of the cervical spine, relieving tender musculature and decreasing frequency, intensity and duration of headaches. Clinical Judgments and Problems List: 1. Decreased AROM of cervical spine 10

11 2. Decreased joint mobility of cervical spine 3. Increased tenderness to palpation of cervical musculature on right side. 4. Positive Quadrant test consistent with positioning pain for CGH. 5. Frequent unilateral headaches lasting hours to days 6. Poor posture contributing to cervical pain and decreased AROM Activity Restrictions: 1. Decreased ability to sit at desk and perform work 2. Decreased ability to stand for long periods of time due to headache intensity 3. Decreased ability to exercise due to headache pain. Goals: 1. Patient will demonstrate independent postural correction 2. Patient will increase pain free cervical AROM and joint mobility to WNL s 3. Patient will increase Patient Specific Functional Scale by 3-point average for sitting, standing, and exercise. Current: Patient will report no greater than 1 incidence of headache per week. Intervention: Patient was educated in postural exercises for head, neck and spine. Patient was asked to stand with back facing a wall. Head and shoulders were to contact wall. Head to assume a chin tuck position to elongate posterior musculature. Patient was also instructed on upper trap stretch and scalene stretch. Patient was instructed to perform postural exercise at least two times per hour while awake. Stretches were to be performed once a day. Manual stretching was performed in supine to right upper trap, right scalenes, and right splenius capitis. Mid-cervical lateral flexion high-velocity-low-amplitude manipulation (HVLAM) with cavitation on right. 11

12 Mid-thoracic extension HVLAM prone, no cavitation T1-2 extension lateral flexion HVLAM prone, no cavitation. Patient reported feeling looser and demonstrated increases of 11 degrees of L cervical rotation and 5 degree loss of R cervical rotation. Visit #2 (8/12/13) Subjective: Patient stated neck feels more relaxed than initial evaluation. Still having 2-3 headaches per week. Currently without headache. Objective: Treatment performed: Manual therapy: HVLAM seated and prone to T1-2 facets left and right, no cavitation HVLAM left and right AA and C3-4 in supine with neck in lateral flexion, cavitation at C3-4. No cavitation at AA. Supine cervical traction; 30lbs with 30/10 sec hold/relax x 17 minutes Assessment: Patient demonstrates increased pain free cervical AROM (visual assessment). However, L rotation (AA) still stiff. Plan: Continue with HEP and weekly treatment sessions. Next session, reassess cervical AROM. Visit #3 (8/19/13) Subjective: Patient stated neck feels looser. Complains of right trap tightness. Stated continues to have 2-3 headaches this week but duration and intensity are less. Reported that HEP seems to be helping with pain relief. Objective: Treatment performed: Manual Therapy: HVLAM in prone to T1-2 facet, no cavitation HVLAM in supine with lateral neck flexion to left and right AA and C3-4, no cavitation. 12

13 Trigger point release to left upper trap. Re-assessment of cervical AROM: L rotation: 50 deg R rot: 55 deg L side bend: 35 deg R side bend: 25 deg Assessment: Measurable increase in cervical AROM. However, L rotation (AA) still stiff. Patient demonstrates progress toward all goals. Plan: Continue weekly treatment sessions. Will revisit cervical traction next session. Visit #4 (8/26/13) Subjective: Patient reports neck continues to feel improved. Reports 2 headaches this week with medium duration and intensity. Patient currently has headache and would like to use traction. Continues to complain of left upper trap tightness. Objective: Treatment performed: Manual therapy: Patient performed L scalene and upper trap stretching Seated first rib inferior glides Supine cervical traction; 30 lbs, 30/10 sec hold/relax x 15 minutes. Patient reported good relief of symptoms. Assessment: Patient continues to require cues for posture. Assessment of cervical AROM appears improved and continues to be pain free. Plan: Patient will continue with HEP. Continue weekly sessions. Visit #5 (9/23/13) Subjective: Patient back in clinic, had called to cancel last two appointments. 13

14 Patient reports increased stiffness in neck but that HEP continues to help with pain relief. Reports headaches two times per week with medium duration and intensity. Objective: Treatment performed: Manual therapy and cervical traction: Manual stretching to L upper traps, L scalenes, and sub-occipitals HVLAM in supine to left and right AA with cavitation HVLAM in supine with lateral flexion to C4-5 with cavitation Cervical traction; 27 lbs with 30/10 hold/relax x 17 minutes Assessment: Patient appears to benefit from above treatment for reduction of neck pain and stiffness. Plan: Reduce frequency to 2 times per month. Will instruct patient on use of home traction on next visit. Visit #6 (10/7/13) Subjective: Patient reported continued neck pain. Continues to perform HEP and has started swimming again. States that headaches are improving with decreased duration and intensity. Objective: Treatment performed: Manual therapy and cervical traction HVLAM in supine to left and right AA with cavitation HVLAM in supine with lateral flexion to C4-5 with cavitation Trial of home, door-hung cervical traction unit. Assessment: Patient appears to benefit from manual therapy and cervical traction for reduction of neck pain and stiffness. Recommend purchase of home traction unit. Plan: Continue with two times a month sessions. Will order patient a home cervical traction unit. 14

15 Visit #7 (11/4/13) Subjective: Patient reports improved neck pain and that neck feels looser. Reports only one headache this week with medium duration and intensity. Reports to still performing HEP and swimming. Feels HEP and exercise are helping. Patient has not received cervical traction unit yet. Objective: Treatment performed: Manual therapy: Trigger point release to left upper trap. HVLAM in supine to left and right AA with cavitation HVLAM in supine with lateral flexion to C5-6 with cavitation Cervical traction; 30 lbs. with 30/10 hold/relax x 15 minutes Assessment: Patient appears to be taking an active role in rehabilitation. Patient continues to benefit from manual therapy and cervical traction for reduction of neck pain and stiffness. Patient reporting less frequent headaches with improved rating of intensity and duration. Plan: Will re-evaluate cervical AROM on next visit. Anticipate that patient will receive home traction unit by next visit. Visit #8 (11/18/13) Subjective: Patient reports that neck is feeling better. Reports having 1 headache this week with medium intensity and duration. States that neck feels like it is moving better. Patient has received home traction unit and reports to using 2 times this week. Patient feels ready to begin management from home with HEP, exercise and traction. Objective: Re-assessment of cervical AROM: L rot: 60 deg 15

16 R rot: 68 deg L side bend: 45 deg R side bend: 37 deg Flexion: 90% Extension: 75% *All ROM pain free (-) quadrant (-) compression Assessment: Patient has benefitted from manual therapy and cervical traction to reduce neck stiffness and pain and is experiencing decreased frequency, duration, and intensity of headaches. Plan: Patient will call to schedule additional appointments if needed. If patient does not call to reschedule appointment in 30 days, patient will be discharged from PT. Review of goals: 1. Patient will demonstrate independent postural correction Outcome: Patient able to demonstrate independent postural corrections for relief of neck pain. Status: Goal met. 2. Patient will increase pain free cervical AROM and joint mobility to WNL s Outcome: Patient increased all cervical AROM from initial evaluation to WFL and is pain free. Status: Goal met. 3. Patient will increase Patient Specific Functional Scale by 3-point average for sitting, standing, and exercise. Current: 3.0 Outcome: Patient score on Patient Specific Functional Scale at end of treatment: 5.67, a 90 % improvement. 4. Patient will report no greater than 1 incidence of headache per week. Outcome: At end of treatment, patient was reporting no greater than 1 incidence of 16

17 headache per week with improved duration and intensity. This patient had good outcomes with a treatment approach tailored around manipulation therapy. With the treatments administered by the therapist, the patient was able to achieve improved cervical AROM and, importantly, reduce frequency, duration and intensity of cervicogenic headaches. The patient did not achieve a headache-free outcome; however, felt that management could be achieved with a home exercise program and exercise. The patient never called back to schedule additional visits and was therefore discharged from physical therapy services. Section 3: Evidence Based Analysis The breadth of research for treatment of cervicogenic headache with the use of spinal manipulative therapy is fairly extensive. The pool of research ranges from high to low levels of evidence. In researching the data for this study, four bibliographical databases were searched. The databases searched were: PUBMED, CINAHL, PEDRO, and SPORTDISCUSS. Search terms used included: physical therapy and cervicogenic headache, spinal manipulative therapy and cervicogenic headache, cervicogenic headache, physical therapy and headache. Figure 1 shows the search method and the decision tree for selecting articles. Overall, 208 articles were identified using the search terms. Of the 208 articles, nine were selected based on title, relevance to topic, and strength of evidence. The nine articles used for analysis ranged from level 1a to 5 on Oxford Levels of 17

18 Evidence Scale. There were 4 systematic reviews; the first looked into manual therapies for CGH, the second at SMT for CGH, the third examined adverse events associated with SMT and the fourth aimed and comparing mobilizations to manipulations for neck pain. There were 2 Randomized Controlled Trials with Oxford Level of Evidence scores of 1b and Pedro Scores of 8/10. There was one case study used with an Oxford Level of 3b and a Pedro Score of 3/10. There was one diagnostic RCT with Oxford Level 2c. Finally, an outcomes research article was used that illustrated an evidence-based approach to CGH. The studies identified were all related to this case study and proved to be valuable data for following the treatment of this report. Table 1 gives the analysis of types of articles, levels of evidence, purpose, outcome measures and results. Included in the appendix of this paper is an analysis of each article, as well as a one page summary of the articles. 18

19 Figure 1: Decision Tree for Research 19

20 # Study Oxford Level of Evidence /PEDro score 1 Chaibi, A., Russell, MB, Posadzki P, Ernst E., 2011 Cochrane Method Used Purpose of Study 1a Not stated The stated purpose was to assess the efficacy of manual therapies for cervicogenic headache. 1a Yes The objective of this SR was to assess the effectiveness of spinal manipulations as a treatment option for cervicogenic headaches. Outcome Measures/ Types of Studies Included The study used 7 RCT s ranging from points on a 100-point scale. 9 RCT s were investigated. The primary outcome of interest was pain management. This study did not sufficiently describe the selection process from study to study. However the authors acknowledge a relatively heterogeneous population across RCT s Results The results showed that patients have a positive response to SMT and that PT and SMT may be an effective treatment in the management of CGH. The treatments offered from study to study are feasible options for a typical clinical setting. The primary skill set is manual therapy, specifically SMT. The primary consideration is the patient s preference to SMT. Results were mostly homogenous from study to study suggesting that SMT is effective in treating CGH. However the data is not conclusive and there continues to be unanswered questions regarding adverse effects of SMT. This article points out many important factors; primarily the lack of reported adverse reactions. While the quality methodology is poor, the RCT s are inconclusive in determining if SMT is a valid treatment option for CGH. Accept Results to Answer Clinical Question Yes Yes 3 Carlesso, LC, et al, a Yes The goal of this SR was to synthesize the literature that has reported adverse events related to both cervical manipulation and mobilization 14 RCT s were selected for review. Primary outcome of interest was any adverse event(s) associated with SMT. While the findings from this SR are inconclusive, there are a few key variables to note. First, the incidence of AE in current literature regarding SMT is grossly underreported. This failure to report leads the authors to conclude that more stringent reporting of AE is required in RCT s as well as in other literature. Second, there were no Catastrophic events reported across any eligible study, however this does not exclude the Yes 20

21 4 Gross A, Miller J, D'Sylva J, et al., Zito, G, Jull, G, Story, I., 2006 techniques across professions. 1a Yes This objective of review was to assess whether manipulation or mobilization improves pain, function/disability, patient satisfaction, quality of life and global perceived effect in adults experiencing neck pain with or without cervicogenic headache or radicular findings. 2c n/a This study examined the presence of cervical musculoskeletal impairment in 77 subjects (27 with cervicogenic headache, 25 with migraine + aura, and 22 control subjects). The aim was to investigate the sensitivity of multiple tests, as a group, to determine if there is a pattern of musculoskeletal dysfunction. 27 RCT s were selected for this review. Outcome measures of interest were pain relief, function, disability, and patient satisfaction, GPE, QoL. No restrictions were set on type of tool used to assess the outcome measures. Most used validated tools to collect data. Assessments included a photographic measure of posture, range of movement, cervical manual examination, pressure pain thresholds, muscle length, performance in the cranio-cervical flexion test and cervical kinesthetic sense. possibility that minor adverse events are occurring and underreported. This SR identified implications for practice that may be used to guide treatment, they are: cervical manipulation and mobilizations provide similar pain relief, functional improvement, and patient satisfaction; cervical manipulation may provide short term but not long term pain relief; thoracic manipulation alone or in combination with electrothermal or individualized physiotherapy treatments may improve pain and function; anterior-posterior mobilizations may be superior to transverse, oscillatory and rotational mobilizations. The results indicated that when compared to the migraine with aura and control groups who scored similarly in the tests, the cervicogenic headache group had less range of cervical flexion/extension (P = 0.048) and significantly higher incidences of painful upper cervical joint dysfunction assessed by manual examination (all P<0.05) and muscle tightness (P<0.05). Sternocleidomastoid normalized EMG values were higher in the latter three stages of the cranio-cervical flexion test although they failed to reach significance. There were no between group differences for other measures. A discriminant analysis revealed that manual examination could discriminate the cervicogenic headache group from the other subjects (migraine with aura and control subjects combined) with an 80% sensitivity. Yes Yes 21

22 6 van Duijn, J, van Duijn, AJ, Nitsch, W., b 2/10 n/a The purpose of this study was to describe the physical therapy differential diagnosis, management with SMT, and outcomes of a patient with cervicogenic headache. Self-report outcome measures included the VAS for headache pain and intensity and the NDI. At time of discharge, the patient had reported no headaches for three weeks. Her NDI score had decreased to 3/50 from an initial level of 20/50, which indicated that a clinically meaningful change had occurred based on the minimal clinically important difference of 7 points. The VAS pain scale score ranged from 0-5 (mm) with some daily variation, compared to a maximal initial level of 80 (mm), which represented a true change based on a minimal detectable change of 28 (mm). Yes 7 Jull, G., et al b 8/10 n/a The purpose of this study was to determine the effectiveness of manipulative therapy and a low-load exercise program for cervicogenic headaches when used alone or in combination, as compared with a control group. The primary outcome was a change in headache frequency. Other outcomes included changes in headache intensity and duration, the Northwick Park Neck Pain Index, medication intake, and patient satisfaction. Physical outcomes included pain on neck movement, upper cervical joint tenderness, a cranio-cervical flexion muscle test, and a photographic measure of posture. At the 12-month follow-up assessment, both manipulative therapy and specific exercise had significantly reduced headache frequency and intensity, and the neck pain and effects were maintained (P < 0.05 for all). The combined therapies was not significantly superior to either therapy alone, but 10% more patients gained relief with the combination. Effect sizes were at least moderate and clinically relevant. The clinical significance of this study suggests that manual therapy is a viable option for the management of CGH and should be considered as a viable option for the treatment of CGH. Furthermore, exercise therapy remains a valuable modality in the treatment of CGH and should not be excluded as a treatment option for CGH. Yes 8 Page, P., n/a The purpose of this clinical suggestion is to review the literature on Relevant background was presented, gaps in current knowledge we addressed and the need As with other musculoskeletal dysfunctions, a multi-modal physical therapy intervention is recommended to address individual impairments including modalities, manual therapy, and Yes 22

23 9 Vavrek D, Haas M, Peterso n D., b 8/10 n/a cervicogenic headache (CGH) and develop an evidence-led approach to assessment and clinical management. The purpose of this RCT was to investigate relationships between objective physical examination measures with selfreported cervicogenic headache outcomes for further research was acknowledged. The clinical importance was clearly discussed. The need for this study arises from the incidence of CGH and the paucity of evidence to direct efficient, evidence-based treatment and management. Of 80 subjects, 40 were randomized to 8 treatments (SMT or light massage control) and 8 PE over 8 weeks. PE included motion palpation of the cervical and upper thoracic regions, active cervical ROM and associated pain, and algometric pain threshold evaluated over articular pillars. Self-reported outcomes included CGH and neck pain and disability, # of CGH headaches, and related disability days. models. therapeutic exercise. It s important for sports physical therapists to make an accurate diagnosis and provide an appropriate intervention to return the athlete with CGHs to sports as soon as possible. At baseline, number of CGH and disability days were strongly associated with cervical active ROM (P <.001 to.037). Neck pain and disability were strongly associated with ROM-elicited pain (P <.001 to.035) but not later in the study. After the final treatment, pain thresholds were strongly associated with week 12 neck pain and disability and CGH disability and disability days (P.001 to.048). This article gives little additional understanding as to the identifying markers for Physical examination to identify CGH. The clinical significance is unchanged from previous strategies to diagnose CGH; which is to cluster signs and symptoms and apply knowledge of physiology to diagnose CGH in the clinic. Yes Table 1: Included Articles 23

24 Discussion: While some RCT s suggest that physical therapy and SMT might be an effective treatment in the management of CGH (Chaibi, Russell, 2012); others suggest that the methodological quality of current RCT s is flawed and cannot be regarded as an evidence-based approach to treatment (Posadski, Ernst, 2011). With the current literature being somewhat polarized in it s conclusions, practitioners must be pragmatic and use clinical judgment along with a strong foundation of physiology and anatomy when examining the conclusions that are drawn about the efficacy of SMT for the treatment of patients with CGH. The ubiquitous criticism of current literature lies in the methodological quality of current studies. Currently there are no set protocols to follow for the collection and reporting of crucial data such as adverse events or SMT as an isolated treatment (as opposed to a multimodal approach). The majority of current RCT s fail to sufficiently or systematically report adverse events that are experienced by the patient when treated with SMT. This failure to report has led to reviewers calling for consort statement extensions on harms reporting guidelines so that mild and moderate adverse events can be captured (Carlesso, et al, 2010). Another common criticism of the current literature was failure to sufficiently blind either tester of participant. However, as with most manual physical therapy blinding will continue to be a difficult task since a clinician will typically know which intervention is being performed. Finally, while the body of evidence on SMT for CGH is growing, there are relatively few RCT s or case studies that examine SMT as an isolated treatment and not as a multimodal approach to treatment. 24

25 While concerns should be raised regarding adverse events associated SMT at the cervical spine, current research reports that no catastrophic outcomes were reported in any of the eligible studies. This includes a prospective study performed by Thiel et al, which reported the performance of 50,276 cervical manipulations (Carlesso, et al, 2010). With that bit of information clinicians should continue to be aware of catastrophic and mild to moderate adverse events that may arise from the use of SMT. Positive implications for practice report that cervical manipulations produce similar pain relief, functional improvements, and patient satisfaction to mobilization and provide short-term pain relief (Gross, et al, 2010). One study performed in Australia concluded that SMT in conjunction with exercise can reduce symptoms of CGH, and the effects are maintained over a 12 month period (Jull, et al, 2002). Finally, a case study that was performed in the US demonstrated that a multimodal approach to the management of patients with CGH can be effective (Duijn, Duijn, Nitsch, 2007). In this case study the authors used trust and non-thrust manipulation, soft tissue manipulation and stretching, muscle re-education and patient education in the management of a patient with CGH. One therapist saw the patient in this case report for eight visits, over the course of three and a half months. The therapist, using special tests, patient history, 25

26 knowledge of physiology and symptomology diagnosed the patient with CGH. The patient was treated using a multimodal approach that included cervical SMT, cervical mobilizations, cervical traction, postural exercises, and cervical traction. The decision to use cervical SMT for this patient was made after considering multiple factors. First, the literature has presented compelling evidence to use SMT as part of a multimodal approach to management of CGH. Second, the patient showed no signs of symptoms of vertebral artery occlusion nor did the patient present as a risk for vertebral artery dissection. Third, the patient had had prior cervical manipulations in the past and requested to have SMT performed. Over the course of treatment the patient was taught self-management with the use of postural exercises, neck stretches, and cervical traction. Therapy sessions consisted of primarily manual therapy, specifically cervical SMT but also included, cervical mobilizations, manual stretching, and cervical traction. The patient initially showed good progress, then had a minor set back after missing scheduled appointments, but ultimately able to reduce frequency, duration, and intensity of headaches as well as return active cervical range of motion to normal limits. Conclusion: The evidence for cervical SMT for the management of CGH proved to be suitable to make the decision to proceed with treatment focused of SMT. While the evidence was not overwhelmingly conclusive, a case can be made for 26

27 positive benefits and outcomes with minimal risk to the patient. This case report was important because it illustrated how a SMT can aid in the management of CGH if used as part of a multimodal approach to achieve a positive patient outcome. This patient was able to achieve nearly all of his physical therapy goals (the exception being 90% completion of the fourth goal) and discharge from treatment with fewer headaches, decreased duration and frequency of headaches, and improved pain free cervical range of motion. Although the patient was not headache free, there were marked improvements in symptoms. For this case report, the PICO question was; In adult patients with cervicogenic headache, how effective is cervical manipulation compared to other conservative treatment in controlling incidence of headache? For this patient, the answer to this question emerges as SMT being at least as effective as other conservative methods of treatment. 27

28 References Carlesso LC, Gross AR, Santaguida PL, Burnie S, Voth S, Sadi J. Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. Man Ther Oct;15(5): Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain Jul;13(5): Goodman CC, Fuller KS, Pathology: Implications for the Physical Therapist third edition. St. Louis, Missouri: Elsevier Inc.; Gross A, Miller J, D'Sylva J, et al. Manipulation or mobilisation for neck pain: a Cochrane Review. Man Ther Aug;15(4): Jull G, et al. A Randomized Controlled Trial of Exercise and Manipulative Therapy for Cervicogenic Headache. Spine. 1 September Volume 27 - Issue 17 - pp Page P, Cervicogenic Headaches: An Evidence-Led Approach To Clinical Management. Int J Sports Phys Ther. Sep 2011; 6(3): Posadzki P, Ernst E. Spinal manipulations for cervicogenic headaches: a systematic review of randomized clinical trials. Headache Jul- Aug;51(7): van Duijn J, van Duijn AJ, Nitsch W, Orthopaedic Manual Physical Therapy Including Thrust Manipulation and Exercise in the Management of a Patient with Cervicogenic Headache: A Case Report. J Man Manip Ther. 2007; 15(1): Vavrek D, Haas M, Peterson D. Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache. J Manipulative Physiol Ther Jun;33(5): Zito G, Jull G, Story I. Clinical tests of musculoskeletal dysfunction in the diagnosis of cervicogenic headache. Man Ther May;11(2): Epub 2005 Jul

29 Appendix 1 Diagnostic Test Evidence Appraisal Worksheet Citation (use AMA or APA format): Zito, G, Jull, G, Story, I. Clinical tests of musculoskeletal dysfunction in the diagnosis of cervicogenic headache. Man Ther May;11(2): Level of Evidence (Oxford scale): 2c Is the purpose and background information sufficient? Study Purpose This study examined the presence of Stated clearly? cervical musculoskeletal impairment in 77 Usually stated briefly in abstract and in subjects (27 with cervicogenic headache, greater detail in introduction. May be 25 with migraine + aura, and 22 control phrased as a question or hypothesis. subjects). The aim was to investigate the A clear statement helps you determine if sensitivity of multiple tests, as a group, to topic is important, relevant and of interest determine if there is a pattern of to you. Consider how the study can be musculoskeletal dysfunction. applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study Relevant background information and a review of literature was provided along with current gaps in current knowledge and the clinical importance if the topic. The justification of the need for this study is that the diagnosis must come before the treatment. Knowing key characteristics of the diagnosis improves clinical decisionmaking and leads to better treatment strategies. Does the research design have strong internal validity? There is sufficient data and description of 29

30 Is there a detailed description of: Setting in which the research was conducted Is this test reproducible in your setting? The sample and how it was obtained Does this resemble your patient population and/or is the sample selection biased in anyway Protocol for the test used including scoring methods. Could you reproduce the test from the descriptions given? the testing that was performed. All measurements were described in detail and could be replicated in another clinical setting. The sample of subjects was obtained through valid and reliable sources. The population was females ranging in age from years old. While this is not the sole demographic for cervocogenic headache, this is a fair representation. This protocol could be replicated with the given descriptions. Are the results of this diagnostic study valid? Yes 1. Was there an independent, masked comparison between the diagnostic test of interest and a gold (reference) standard diagnostic test? a. If not, describe what was done, the limitations of this approach, and the potential consequences for the study s results 2. Was the diagnostic test evaluated in subjects with the range of presentation (i.e., different levels or stages) of the condition? a. If not, describe the sample and discuss the potential consequence that this limited sample has for the study results 3. Did the investigators perform the gold standard diagnostic test on every subject regardless of the result from the diagnostic test of There was an independent masked comparison between groups in that the single examiner was not aware of the diagnoses prior to examination. The gold standard for diagnosis of CGH was a diagnosis reached using Sjaastad et al., 1998 criteria. IHS, 2004 criteria for migraine headache. Limitations of this approach are the examiners skill level and the inter-rater reliability of the testing. The testing was performed on subjects with varying total length of history ranging from 9 months 10 years. Gold standard testing was performed on each subject regardless of the results from the diagnostic test of interest. 30

31 interest? a. If not, describe what was done, as well as the limitations of this approach. 4. Was the test (or cluster of tests) evaluated in a second independent group of subjects? Did the investigators confirm their findings with a new set of subjects? a. If not, describe the limitations resulting from the lack of comparison group 5. Were the individuals performing the test masked or blinded to the other test s results? a. If not, what are the potential consequences of this knowledge for this study s results The test was not evaluated by a second, independent group of subjects. Findings were not confirmed with a new set of subjects. The limitations resulting from a lack of comparison are in reliable measurements. There is no data to suggest that these tests are reproducible given different testers in a new location. There was a single tester who was blinded to the diagnosis of each patient. Are the valid results of this diagnostic study important? Fairly 6. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of association With p-values and CI c. Sensitivity/ specificity d. Positive predictive value/ negative predictive value e. LR + and LR- with CI f. Other stats should be included here With the given data, 2 co-variables were found to be diagnostic indicators of CGH vs. migraine and control: 1) upper cervical joint dysfunction at the C1/2 segments paired with 2) pectoralis minor muscle length. Given these two variables the researchers report a sensitivity of 0.8. Given raw data from C1/2 segments (raw data not given for pec minor): Specificity=0.76 Please see calculation below for PPV, LR-, LR+, Pre/Post-test probability, nomogram. 7. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? This data suggests a fair diagnostic value can be taken when using C1/2 dysfunction along with pectoralis minor muscle length. For practice, evaluating C1/2 and pectoralis minor are important variables in diagnosing CGH and ultimately the treatment direction. 31

32 Can you apply this valid, important evidence about this diagnostic test in caring for your patient/client? What is the external validity? Yes, external validity is fair. 8. Does this test sound appropriate Considering availability and affordability, for use (available, affordable) in this test appears appropriate for use in a your clinical setting? clinical setting. 9. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this test in spite of the differences? 10. Can you generate a clinically sensible estimate of your patient s pretest probability of the disorder? a. Talk about your interpretation of the nomogram 11. Would the test and its results, including the posttest probabilities help your patient? a. If so, how? If not, could the test actually harm your patient? This study is focused on females only. Without further research the implications do not cross to over to male populations. Given the inherent differences in the male and female anatomy, additional diagnostic criteria must be examined in male subjects. Given the data from this study, the pretest probability is 35%. This appears to be a sensible estimate given the prevalence of the condition. The nomogram gives further diagnostic confidence when applying the C1/2 criteria. Given raw data from pectoralis testing the probabilities could potentially increase, giving the diagnostic tools greater probability of correct diagnosis. Yes. The results give greater confidence to the diagnosis allowing the clinician to guide treatment in an appropriate direction. 12. Does the test fit within your patient s stated beliefs or expectations? What are the risks vs. benefits? Cost? What is the bottom line? Summarize your findings and relate this back to clinical significance and usefulness of this test Generally, patients want to know why their bodies feel bad. The conservative testing involved with this research is fairly fast, relatively inexpensive and within the scope of practice of any physical therapist. Risks are low; potentially provoking some CGH associated pain. Benefits are moderately high; correct diagnosis increases probability of positive outcome. This study suggests that C1/2 testing in conjunction with pectoralis minor muscle length testing can be useful in the 32

33 diagnosis of CGH. The clinical significance lies in the testing parameters, C1/2 testing and muscle length testing are universal skills in nearly every practice. Additionally, the testing requires no additional cost or risk to the patient making it a viable option for first line diagnosis. 33

34 Calculations if needed: given raw data from c1/2 dysfunction (no pec minor data) Target Disorder Diagnostic test + - Totals results + a b a+b - c d c+d Totals a+c b+d a+b+c+d Sensitivit y = a / (a + c) = 39 / ( ) = 39 / 54 = 73 %_ Specificit y = d / b + d = 76 / ( ) = 76 / 100 = 76 % Positive Predictive Value Negative Predictive Value = a / (a + b) = 39 / = 39 / 64 = 61 % = d / (c + d) = 76 / ( ) = 76 / 91 = 84 % Positive Likelihood Ratio (LR+) = Sensitivity / (100 - specificity) = 80 % / (100 - _76 %_) = 80 / _24 = 3.33 Negative Likelihood Ratio = (100 - sensitivity) / specificity 34

35 (LR-) = (100- _80 %) / _76 % = 20 / 76 = _0.26 Pretest probability (prevalence) = (a+c) / (a+b+c+d) = (_39 + _15 ) / (_39 + _24 +_15 +_76 ) = 54 / 154 = 35 % Use the nomogram to determine post-test probability: Draw a line to represent your answer for both a positive test and a negative test. Here are lines you can drag and expand to put on your graph: 35

36 Interpretation of the Nomogram (is this diagnostic test clinically useful?): Given the above statistics a clinician can increase the probability of correct diagnoses by 28% using positive findings from a C1/2 dysfunction test as diagnostic tool. Conversely a clinician can increase confidence of ruling out CGH from 35% probability to roughly 12% (a difference of 23%) probability by using c1/2 diagnostic criteria. Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

37 Zito, G, Jull, G, Story, I. Clinical tests of musculoskeletal dysfunction in the diagnosis of cervicogenic headache. Man Ther May;11(2): Level of evidence: 2c Purpose: This study examined the presence of cervical musculoskeletal impairment in 77 subjects (27 with cervicogenic headache, 25 with migraine + aura, and 22 control subjects). The aim was to investigate the sensitivity of multiple tests, as a group, to determine if there is a pattern of musculoskeletal dysfunction. Methods: Seventy-seven female volunteers aged between 18 and 34 years were invited to join the study. The cross- sectional study was conducted under single blind conditions in that the principal investigator, an experienced musculoskeletal physiotherapist, was blind to the diagnostic category of the subjects. The subjects were recruited from neurologists, general medical practitioners and musculoskeletal physiotherapists or by advertisement. They entered one of three groups, a control group a cervicogenic headache group or a migraine with aura group and comparisons between the three groups were made. Headache subjects entered their respective groups according to established diagnostic criteria for migraine with aura and cervicogenic headache. Anesthetic blockades were not used as a criterion for cervicogenic headache as the procedure was considered too invasive and costly for this study and is not readily accessible to most clinicians. The total length of the history of the headache ranged from 9 months to more than 10 years. Young subjects were selected as it is the period of life when vascular symptoms are more frequently encountered and when the effects of age or disease in the musculoskeletal system are still relatively negligible. The inclusion criteria for control subjects were no history of headache, cervical pain or injury for which they had sought treatment. Headache subjects were deemed ineligible if they had a history of combined forms of headache, were involved in compensation or, in the case of migraine with aura subjects, if they had a history of a neck injury or condition. Results: The results of this study determined that range of cervical movement was reduced in the cervicogenic headache subjects, albeit significant for flexion and extension only. This finding of reduced movement supports the current criteria for cervicogenic headache. Bottom Line: This study determined that the presence of upper cervical joint dysfunction most clearly differentiated the cervicogenic headache sufferers from those with migraine with aura and control subjects. The cervicogenic headache group also presented with restriction in cervical motion, a higher frequency of muscle tightness. This data is useful in the treatment of cervicogenic headache because the diagnostic criteria fit the current model of dysfunction in patients with cervicogenic headache. 37

38 Appendix 2 Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): van Duijn J, van Duijn AJ, Nitsch W. Orthopaedic Manual Physical Therapy Including Thrust Manipulation and Exercise in the Management of a Patient with Cervicogenic Headache: A Case Report. J Man Manip Ther. 2007; 15(1): Level of Evidence (Oxford scale): 3b Is the purpose and background information sufficient? Study Purpose Stated clearly? Usually stated briefly in abstract and in greater detail in introduction. May be phrased as a question or hypothesis. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? The purpose of this study was to describe the physical therapy differential diagnosis, management, and outcomes of a patient with cervicogenic headache (CGH). Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study The authors discuss the current literature and the need for further high-level evidence to support or refute the use of cervical manipulation as a viable treatment option for CGH. This study justifies treatment based on current industry standards of diagnosis and treatment. Does the research design have strong internal validity? Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression Possible threats to internal validity include, followup times (6 mos. and 1 yr.) as well as an appeal to authority on the part of the patient. These variables question the validity of true long-term carry-over as well as the subjective feelings of the patient when followed over time. 38

39 Are the results of this therapeutic trial valid? 1. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 2. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 3. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 4. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 5. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 6. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 7. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 8. Did all the subjects originally enrolled complete the study? This article is a case report. There was single subject who was treated for CGH using thrust and non-thrust manipulation techniques, exercise, and postural correction. There was no blinding in this study. Potential consequences are no comparison to a gold standard of treatment. The reported outcome comes from the therapist who has gathered the data from the patient. There was only one subject in this study. This effectively makes this a 3b level of evidence. Yes. The patient may have felt a need to appeal to the authority of the therapist. Yes. However, there was a pre-designed treatment plan that the therapist followed. This treatment may not have large carry-over to large pools of patient populations. N/A Follow-up time was 6mos and 1yr. This was a fair amount of time to examine the long term effects of the treatment. However, even longer follow-up would aid in the determination to label the results a positive long term outcome. Yes 39

40 a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? 9. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Yes, no data was excluded. Are the valid results of this RCT important? 10. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-values and CI c. Include effect size with p-values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here 11. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? 12. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Statistics were not performed in this study. Statistics were not performed in this study Statistics were not performed in this study Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? 13. Does this intervention sound appropriate for use (available, affordable) in your clinical setting? Do you have the facilities, skill set, time, and 3rd party coverage to provide this treatment? This intervention is appropriate for us in a clinical setting. There are minimal tools needed and the cost is relatively low given that there is no additional equipment needed. 40

41 14. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 15. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 16. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? 17. Are there any threats to external validity in this study? What is the bottom line? PEDRO score (see scoring at end of form) This subject appears similar to other patients with this diagnosis. The benefits outweigh the potential risks. This intervention fits within most patients values and expectations. The primary consideration is whether the patient has a aversion to cervical manipulation. There are situational threats to external validity. There were multiple modalities used to treat (i.e. thrust, non-thrust manipulation, exercise and postural exercises) there is no clear indication that one of these modalities works better than. This must be a consideration when choosing treatment modalities. 2/10 Summarize your findings and relate this back to clinical significance This is a fair case report that uses data from multiple sources to treat a single patient with CGH. The modalities chosen reflect the best current evidence and should be considered when treating patients with CGH. The largest considerations remaining are whether all modalities are needed or if individual components of this treatment can be effective. 41

42 van Duijn J, van Duijn AJ, Nitsch W. Orthopaedic Manual Physical Therapy Including Thrust Manipulation and Exercise in the Management of a Patient with Cervicogenic Headache: A Case Report. J Man Manip Ther. 2007; 15(1): Level of Evidence (Oxford scale): 3b Purpose: The purpose of this study was to describe the physical therapy differential diagnosis, management, and outcomes of a patient with cervicogenic headache (CGH). Methods: The patient was a 40-year-old woman referred by her physiatrist with complaints of cervical pain and ipsilateral temporal headache. The patient presented with increased muscle tone, multiple-level joint hypomobility in the cervical and thoracic spine, muscle weakness, and postural changes. Self-report outcome measures included the Visual Analog Scale for headache pain intensity and the Neck Disability Index. Management consisted of various thrust and non-thrust manipulations, soft tissue mobilizations, postural re-education, and exercise to address postural deficits and cervical and thoracic hypomobility and diminished strength. Results: At discharge, the patient demonstrated clinically meaningful improvements with regard to pain, disability, and headache. The patient was seen for a total of 16 visits over a 9-week period of time. The initial frequency of treatment was 3 times per week and was gradually decreased to once weekly during Weeks 6-9 to monitor progression of the home program. At time of discharge, the patient had reported no headaches for three weeks. Her NDI score had decreased to 3/50 from an initial level of 20/50, which indicated that a clinically meaningful change had occurred based on the minimal clinically important difference of 7 points. The VAS pain scale score ranged from 0-5mm with some daily variation, compared to a maximal initial level of 80mm, which represented a true change based on a minimal detectable change of 28mm. The location of the remaining pain was in the upper thoracic region. Bottom Line: A multimodal PT treatment approach was used based on evidence in the literature and pathophysiologic hypotheses, and it included the use of non-thrust and thrust manipulation techniques, therapeutic exercise, and postural correction. Clinically meaningful short- and long-term improvements with regard to pain, disability, and headache were reported with at least a temporal relation to this treatment approach. Physical therapy management of the cervical headache patient should address all identified impairments with interventions including non-thrust joint manipulation, HVLA thrust manipulation, soft tissue manipulation and stretching techniques, retraining specific postural muscle groups, and patient education. 42

43 Appendix 3 Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): Gwendolen J, et al. A Randomized Controlled Trial of Exercise and Manipulative Therapy for Cervicogenic Headache. Spine. 1 September Volume 27 - Issue 17 - pp Level of Evidence (Oxford scale): 1b Is the purpose and background information sufficient? Study Purpose The purpose of this study was to Stated clearly? determine the effectiveness of Usually stated briefly in abstract and in manipulative therapy and a low-load greater detail in introduction. May be exercise program for cervicogenic phrased as a question or hypothesis. headaches (CGH) when used alone or in A clear statement helps you determine if combination, as compared with a control topic is important, relevant and of interest group. to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study The researchers presented relevant current data for this topic, acknowledged gaps in current knowledge and gave rationale for the clinical importance of this topic. This study aimed to answer the question of modality options for the treatment of CGH. Does the research design have strong internal validity? Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Attrition, history, compensatory rivalry, are all possible threats to internal validity in this research design. The loss of patients needs to be addressed through intention to treat analysis. History, while not a large factor in this study, needs to be considered as events in certain areas of the country can effect the outcome of the study. Finally, the subjects know which group 43

44 Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression they belong, making compensatory rivalry a real threat to internal validity. Are the results of this therapeutic trial valid? 1. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 2. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 3. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 4. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results Yes, the researchers used a randomized permuted block design. This process allows for reasonable allocation of subjects into each group. No. Yes, demographics were reported. The between-group differences were not a threat to the research validity nor would they affect the results of the study. The subjects knew which group they were assigned. Possible compensatory rivalry may have affected the results of the data. 44

45 5. Did the investigators know to which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 6. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 7. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 8. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? 9. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Yes, potential consequences are biases towards certain interventions. Yes, all groups were managed equally. Follow-up time was at 3, 6, and 12 months. This is a fair amount of time to answer the question posed. However, longer follow-up times may indicate greater results and carry-over of treatment. Of the 200 participants, 7 did not complete the study. The authors performed an intention to treat analysis. The reasons for loss of participants were noted and did not greatly affect the results. There was an intention to treat analysis performed in this study. The authors report that the effect size of the active treatments could possibly be an underestimate. Are the valid results of this RCT important? Yes 45

46 10. What were the statistical findings of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-values and CI c. Include effect size with p- values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here There was no raw data reported in this study. Wilcoxon analysis showed manipulation therapy, exercise therapy and manual therapy + Exercise therapy to significantly reduce headache frequency, intensity and neck pain both after initial treatment and 12 months post-treatment with P<0.05 for all. Effect size of 0.5 was regarded as medium and 0.8 as large. For Frequency, Intensity, duration, and neck pain effect sizes for each intervention were respectively: manipulation therapy (0.71, 0.62, 0.33, 0.53), Exercise (0.87, 0.72, 0.00, 0.56), Manual + Exercise (0.68, 0.76, 0.53, 0,64). 11. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? 12. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? This data suggests that both manipulative and exercise therapy, individually can significantly reduce headache frequency, intensity and neck pain at both initial treatment and 12 month follow-up intervals. Effect size s for these variables were at least moderate and have clinical relevance. MCID was not reported in this study, However, given the data this evidence suggests that exercise alone and manipulative therapy alone are at least moderately effective in relieving CGH. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? 13. Does this intervention sound This is an affordable and highly available appropriate for use (available, treatment option for patients with CGH. affordable) in your clinical The only limiting factor in choosing either setting? Do you have the of the effective treatment options is skill facilities, skill set, time, and 3rd set and patient preference/beliefs. party coverage to provide this treatment? 14. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in The subjects appear similar to other patients commonly seen for this condition. 46

47 spite of the differences? 15. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 16. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? 17. Are there any threats to external validity in this study? What is the bottom line? PEDRO score (see scoring at end of form) Benefits do outweigh the potential risks using any of the effective treatment options. The limiting factors in manipulative therapy in the skill level the clinician and the values/beliefs of the patient (i.e. does the patient prefer manipulation or exercise based approach to treatment?) External threats include situational limitations such as location, timing of treatment, treatment administration, and the extent of measurement of the data. 8/10 Summarize your findings and relate this back to clinical significance This RCT shows that manipulative therapy and exercise therapy are effective at reducing the frequency and intensity of CGH as well a relieving neck pain at immediate intervention and 12 month follow-up. The clinical significance of this study suggests that manual therapy is a viable option for the management of CGH and should be considered as a viable option for the treatment of CGH. Furthermore, exercise therapy remains a valuable modality in the treatment of CGH and should not be excluded as a treatment option for CGH. 47

48 Jull G, et al. A Randomized Controlled Trial of Exercise and Manipulative Therapy for Cervicogenic Headache. Spine. 1 September Volume 27 - Issue 17 - pp Level of Evidence (Oxford scale): 1b Purpose: The purpose of this RCT was to determine the effectiveness of manipulative therapy and a low-load exercise program for cervicogenic headache when used alone and in combination, as compared with a control group. Methods: In this study, 200 participants who met the diagnostic criteria for cervicogenic headache were randomized into four groups: manipulative therapy group, exercise therapy group, combined therapy group, and a control group. The primary outcome was a change in headache frequency. Other outcomes included changes in headache intensity and duration, the Northwick Park Neck Pain Index, medication intake, and patient satisfaction. Physical outcomes included pain on neck movement, upper cervical joint tenderness, a craniocervical flexion muscle test, and a photographic measure of posture. Results: There were no differences in headache-related and demographic characteristics between the groups at baseline. The loss to follow-up evaluation was 3.5%. At the 12-month follow-up assessment, both manipulative therapy and specific exercise had significantly reduced headache frequency and intensity, and the neck pain and effects were maintained. The combined therapies were not significantly superior to either therapy alone, but 10% more patients gained relief with the combination. Effect sizes were at least moderate and clinically relevant. Bottom Line: This trial provided evidence that manipulative therapy and a specific therapeutic exercise regimen were effective for cervicogenic headache, although there was no statistical evidence of an additive effect when the two therapies were used simultaneously. Beneficial effects were found for headache frequency and intensity as well as neck pain and disability for both therapeutic methods used alone and in combination. For headache duration, exercise used alone did not have a significant effect, and manipulative therapy used alone was not different from the control condition at month 12. Medication intake was reduced in all the active treatment groups. This trial also provided evidence, not available for many of the trials of physical therapies, that treatment effect was maintained in the long term over the 12-month period. 48

49 Appendix 4 Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): Page P. Cervicogenic Headaches: An Evidence-Led Approach To Clinical Management. Int J Sports Phys Ther. Sep 2011; 6(3): Level of Evidence (Oxford scale): 5 Is the purpose and background information sufficient? Study Purpose The purpose of this clinical suggestion is Stated clearly? to review the literature on cervicogenic Usually stated briefly in abstract and in headache (CGH) and develop an greater detail in introduction. May be evidence-led approach to assessment and phrased as a question or hypothesis. clinical management. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study Relevant background was presented, gaps in current knowledge we addressed and the need for further research was acknowledged. The clinical importance was clearly discussed. The need for this study arises from the incidence of CGH and the paucity of evidence to direct efficient, evidence-based treatment and management. Does the research design have strong internal validity? Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Testing This article merely reviews current literature to make a clinical suggestion about the intervention and management of patients with CGH. 49

50 Compensatory Equalization of treatments Compensatory rivalry Statistical Regression Are the results of this therapeutic trial valid? 1. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 2. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 3. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 4. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 5. Did the investigators know to This article merely reviews current literature to make a clinical suggestion about the intervention and management of patients with CGH. This article merely reviews current literature to make a clinical suggestion about the intervention and management of patients with CGH. This article merely reviews current literature to make a clinical suggestion about the intervention and management of patients with CGH. This article merely reviews current literature to make a clinical suggestion about the intervention and management of patients with CGH. 50

51 which treatment group subjects were assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 6. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 7. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 8. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? 9. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? This article merely reviews current literature to make a clinical suggestion about the intervention and management of patients with CGH. This article merely reviews current literature to make a clinical suggestion about the intervention and management of patients with CGH. This article merely reviews current literature to make a clinical suggestion about the intervention and management of patients with CGH. This article merely reviews current literature to make a clinical suggestion about the intervention and management of patients with CGH. Are the valid results of this RCT important? 10. What were the statistical findings No statistics were performed in this article 51

52 of this study? a. When appropriate use the calculation forms below to determine these values b. Include: tests of differences With p-values and CI c. Include effect size with p- values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here 11. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? 12. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? Statistics were not performed in this article. This article does not provide MCID information. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? 13. Does this intervention sound The interventions discussed in this article appropriate for use (available, suggest that there are multiple approaches affordable) in your clinical to the management of CGH. The selection setting? Do you have the of the intervention lies in the hands of the facilities, skill set, time, and 3rd clinician and should be considered in party coverage to provide this conjunction with the patient s beliefs. treatment? 14. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 15. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? This review does not have subjects. This article iterates that a treatment approach be focused on the correct diagnoses. Following a thorough examination a correct diagnoses can be 52

53 16. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? 17. Are there any threats to external validity in this study? made. If the clinician diagnoses CGH given the outlines criteria from the current literature, then treatment must be focused on the patients impairments using bestevidence which is covered in the article. There are multiple interventions discussed in this article. For the purposes of applying the article to CGH and manipulation therapy, there is evidence sited in this article that suggests spinal manipulation therapy in the upper cervical spine can be beneficial. No What is the bottom line? PEDRO score (see scoring at end of form) 0/10, this is a clinical suggestion for intervention using current best evidence as a guideline. Summarize your findings and relate this back to clinical significance This article iterates the importance of a thorough examination. There are multiple factors that must be considered when diagnosing CGH including myofascial dysfunction, segmental mobility impairment, postural changes, body habitus, and A/PROM. Clinically, this article offers guidance for diagnosis and management of patients suffering from CGH. 53

54 Page, P. Cervicogenic Headaches: An Evidence-Led Approach To Clinical Management. Int J Sports Phys Ther. Sep 2011; 6(3): Level of Evidence (Oxford scale): 5 Purpose: The purpose of this clinical suggestion is to review the literature on cervicogenic headache (CGH) and develop an evidence-led approach to assessment and clinical management. Methods: The author of this clinical suggestion compiled physiological data along with diagnostic criteria for CGH from Dr. Ottar Sjaastad in an attempt to outline and guide clinicians in the assessment, diagnosis, and treatment of CGH. Results: CGHs are caused by neck dysfunction, typically of the upper cervical spine, although the specific etiology remains unclear. Cervicogenic head- aches are associated with musculoskeletal dysfunction and muscle imbalance with characteristic patterns of muscle weakness and tightness. Bottom Line: Diagnosis of treatment is a multifactorial process. The examiner must consider and assess all tissues that may play a role in contributing to CGH. As with other musculoskeletal dysfunctions, a multi-modal physical therapy intervention is recommended to address individual impairments including modalities, manual therapy, and therapeutic exercise. 54

55 Appendix 5 Intervention Evidence Appraisal Worksheet Citation (use AMA or APA format): Vavrek D, Haas M, Peterson D. Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache. J Manipulative Physiol Ther Jun;33(5): Level of Evidence (Oxford scale):1b Is the purpose and background information sufficient? Study Purpose The purpose of this RCT was to Stated clearly? investigate relationships between objective Usually stated briefly in abstract and in physical examination (PE) measures with greater detail in introduction. May be self-reported cervicogenic headache phrased as a question or hypothesis. outcomes. A clear statement helps you determine if topic is important, relevant and of interest to you. Consider how the study can be applied to PT and/or your own situation. What is the purpose of this study? Literature Relevant background presented? A review of the literature should provide background for the study by synthesizing relevant information such as previous research and gaps in current knowledge, along with the clinical importance of the topic. Describe the justification of the need for this study This article presents relevant background information in the area of chronic CGH. This article reviews the currently large gap in knowledge of diagnosis, treatment, and outcomes of physical therapy related treatments for CGH. Furthermore, there is a need for use of surrogate markers of CGH pain because these measures have not yet been established. Does the research design have strong internal validity? Discuss possible threats to internal validity in the research design. Include: Assignment Attrition History Instrumentation Maturation Possible threats to internal validity include: Instrumentation, measuring and testing are possible threats to internal validity of this study. The fact that there were 4 separate chiropractors performing the examinations 80 participants raises question as to the inter-rater reliability of both diagnosis and treatment. 55

56 Testing Compensatory Equalization of treatments Compensatory rivalry Statistical Regression Are the results of this therapeutic trial valid? 1. Did the investigators randomly assign subjects to treatment groups? a. If no, describe what was done b. What are the potential consequences of this assignment process for the study s results? 2. Did the investigators know who was being assigned to which group prior to the allocation? a. If they were not blind, what are the potential consequences of this knowledge for the study s results? 3. Were the groups similar at the start of the trial? Did they report the demographics of the study groups? a. If they were not similar what differences existed? b. Do you consider these differences a threat to the research validity? How might the differences between groups affect the results of the study? 4. Did the subjects know to which treatment group they were assign? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 5. Did the investigators know to which treatment group subjects were Subjects were randomly assigned to each group using computer-generated, designadaptive allocation, which, according to the authors, a minimization technique to balance potential cofounders across groups. Study group allocation was concealed from all study personnel before randomization. Statistically speaking, all groups were relatively similar with the exceptions of smoking and race. The light massage (LM) group had no smokers and the spinal manipulation group had 5 smokers. This may have had an effect on the results considering the negative impact smoking has to healing, and vasculature. Subject groups knew which group they were assigned. Potential consequences to this include compensatory rivalry, which could skew results if subjects feel that treatment is being withheld or if subjects feel they are part of the study group. It is unclear if the investigators were blinded to assignment of treatment groups. 56

57 assigned? a. If yes, what are the potential consequences of the subjects knowledge for this study s results 6. Were the groups managed equally, apart from the actual experimental treatment? a. If not, what are the potential consequences of this knowledge for the study s results? 7. Was the subject follow-up time sufficiently long to answer the question(s) posed by the research? a. If not, what are the potential consequences of this knowledge for the study s results? 8. Did all the subjects originally enrolled complete the study? a. If not how many subjects were lost? b. What, if anything, did the authors do about this attrition? c. What are the implications of the attrition and the way it was handled with respect to the study s findings? 9. Were all patients analyzed in the groups to which they were randomized (i.e. was there an intention to treat analysis)? a. If not, what did the authors do with the data from these subjects? b. If the data were excluded, what are the potential consequences for this study s results? Are the valid results of this RCT important? 10. What were the statistical findings of this study? a. When appropriate use the Groups were managed equally. Follow-up time of 12 weeks was sufficient time to answer the question of CGH markers had been identified. All subjects did not complete the study; one subject was lost from the SMT group due to refusal. One subject was lost from the LM group due to no response. Authors performed an intention to treat analysis for every subject. With respect to findings, the intention to treat analysis had no affect. There was an intention to treat analysis performed on each participant included in the original allocation groups; missing data were imputed. Data was not excluded, merely averaged or rolled forward depending on the timing of the data missed. Statistically significant differences were observed between adjusted means only for pain on right rotation and pain on 57

58 calculation forms below to determine these values b. Include: tests of differences With p-values and CI c. Include effect size with p- values and CI d. Include ARR/ABI and RRR/RBI with p-values and CI e. Include NNT and CI f. Other stats should be included here cervical extension (P= and 0.035). The adjusted group differences were moderate in magnitude: -1.0 (-1.8, -0.1) and -1.0 (-1.9, -0.1) respectively. 11. What is the meaning of these statistical findings for your patient/client s case? What does this mean to your practice? 12. Do these findings exceed a minimally important difference? Was this brought up or discussed? a. If the MCID was not met, will you still use this evidence? This means that the only statistically significant differences are pain with right rotation and with cervical extension; however there is a fairly large confidence interval and the results may not be clinically significant. The MCID was brought up in the article and the authors conclude that no consistent surrogate PE measure for CGH was identified. This data can be used to help guide further research and, hopefully, guide topics for the use of SMT vs. conservative treatment. Can you apply this valid, important evidence about an intervention in caring for your patient/client? What is the external validity? 13. Does this intervention sound The interventions used in this article seem appropriate for use (available, appropriate. They are relatively affordable) in your clinical setting? inexpensive and widely available in a PT Do you have the facilities, skill set, office. time, and 3rd party coverage to provide this treatment? 14. Are the study subjects similar to your patient/ client? a. If not, how different? Can you use this intervention in spite of the differences? 15. Do the potential benefits outweigh the potential risks using this intervention with your patient/client? 16. Does the intervention fit within your patient/client s stated values or The subjects in this study were somewhat similar to the typical patient/client however, this study had roughly 78% female. The client of interest in the current report in male. The potential benefits are possible relief of self-reported pain. For the patient of interest the risks do not outweigh the potential benefit. Given the results of this study, the intervention would not fit patient values 58

59 expectations? a. If not, what will you do now? 17. Are there any threats to external validity in this study? due to lack of positive results or sufficient relief. Further data in needed to provide sufficient treatment. As a whole, there is good generalizability to most aspects of this study. What is the bottom line? PEDRO score (see scoring at end of form) 8/10 Summarize your findings and relate this back to clinical significance This article gives little additional understanding as to the identifying markers for Physical examination to identify CGH. The clinical significance is unchanged from previous strategies to diagnose CGH; which is to cluster signs and symptoms and apply knowledge of physiology to diagnose CGH in the clinic. 59

60 Vavrek D, Haas M, Peterson D. Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache. J Manipulative Physiol Ther Jun;33(5): Level of Evidence (Oxford scale): 1b Purpose: The purpose of this RCT was to investigate relationships between objective physical examination (PE) measures with self-reported cervicogenic headache outcomes. Methods: Of 80 subjects, 40 were randomized to 8 treatments (spinal manipulative therapy or light massage control) and 8 PE over 8 weeks. The remaining subjects received no PE. Physical examination included motion palpation of the cervical and upper thoracic regions, active cervical range of motion and associated pain, and algometric pain threshold evaluated over articular pillars. Self-reported outcomes included CGH and neck pain and disability, number of CGH headaches, and related disability days. Associations between PE and self-reported outcomes were evaluated using generalized linear models, adjusting for sociodemographic differences and study group. Results: At baseline, number of CGH and disability days was strongly associated with cervical active ROM. Neck pain and disability was strongly associated with ROM-elicited pain but not later in the study. After the final treatment, pain thresholds were strongly associated with week 12 neck-pain and disability and CGH disability and disability days. Bottom Line: At 12 weeks, a lower pain pressure threshold was indicative of those that still had the most intense subjective experience with headache pain vs. cervical active ROM and pain with movement. This relationship is different from that at baseline, where the reverse was true. It is also important to note that cervical extension remained restricted throughout the study. Although this is useful information for the practicing clinician who may use these PE indicators to track patient progress, no consistent surrogate PE measure for the CGH experience is indicated. 60

61 Appendix 6 Systematic Review Evidence Appraisal Worksheet Citation (use AMA or APA format): Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain Jul;13(5): Level of Evidence (Oxford scale):1a Does the design follow the Cochrane method? Step 1 formulating the question The focus of this paper was to Do the authors identify the focus of the review systematically review RCT s assessing the efficacy of manual therapies for A clearly defined question should specify the types of: cervicogenic headache. The outcome of interest is implied to be improvement of people (participants), CGH symptoms. The researchers interventions or exposures, identified 7 articles of which they examined in an attempt to answer their question. outcomes that are of interest studies that are relevant to answering the question Step 2 locating studies Should identify ALL relevant literature Did they include multiple databases? Was the search strategy defined and include: o Bibliographic databases used as well as hand searching o Terms (key words and index terms) o Citation searching: reference lists o Contact with experts to identify grey literature (body of materials that cannot be found easily through conventional channels such as A thorough, although not all inclusive, search was performed on major databases with key words to maximize relevant results. A list of search terms was included in the article. There was no mention of any attempt to identify grey literature. 61

62 publishers) o Sources for grey literature Part 3:Critical Appraisal/Criteria for Inclusion Were criteria for selection specified? Did more than one author assess the relevance of each report Were decisions concerning relevance described; completed by non-experts, or both? Did the people assessing the relevance of studies know the names of the authors, institutions, journal of publication and results when they apply the inclusion criteria? Or is it blind? Part 3 Critically appraise for bias: Selection Were the groups in the study selected differently? Random? Concealed? Performance- Did the groups in the study receive different treatment? Was there blinding? Attrition Were the groups similar at the end of the study? Account for drop outs? Detection Did the study selectively report the results? Is there missing data? Part 4 Collection of the data Was a collection data form used and is it included? Are the studies coded and is the Criteria for selection was prioritized by Language, the use of manual therapies in CGH, preference of diagnosis as determined using the criteria from International Headache Society (either 1988 or 2004 criteria), studies had to evaluate at least one CGH outcome measure. The first author assessed methodological quality of the included RCT studies. It was not stated whether the assessors knew the names of the publications or results prior to the inclusion criteria. Selected articles were scored out of a 100 point system with scores of 50 or higher considered to be methodology of good quality. All groups in each study were selected through clinical interview, which is considered to be the most valid method in establishing a precise headache diagnosis. Only one study failed to blind the participant to the intervention. Of the seven RCT s one applied physiotherapy + temporomandibular mobilization techniques and the other six applied cervical spinal manipulative therapy (SMT). The authors did not indicate of the RCT s accounted for dropouts. The authors point out that the data was reported accurately however, no mention was made as to missing data. A collection data form was used and included in the paper. The studies have been coded according to the author s criteria and the coding is easy to follow. 62

63 data coding easy to follow? Were studies identified that were excluded & did they give reasons why (i.e., which criteria they failed). Studies were identified that were excluded due to lack of inclusion criteria, however the authors did not state why or which criteria excluded specific articles. Are the results of this SR valid? 1. Is this a SR of randomized trials? Did they limit this to high quality studies at the top of the hierarchies a. If not, what types of studies were included? b. What are the potential consequences of including these studies for this review s results? 2. Did this study follow the Cochrane methods selection process and did it identify all relevant trials? a. If not, what are the consequences for this review s results? 3. Do the methods describe the processes and tools used to assess the quality of individual studies? a. If not, what are the consequences for this review s results? 4. What was the quality of the individual studies included? Were the results consistent from study to study? Did the investigators provide details about the research validity or quality of the studies included in review? This is a homogenous SR of RCT s. The evaluation process ensured that only articles considered to be methodology of good quality were selected. The criteria list was included in the article. These article are of the highest quality of the given search. There were only seven articles that fit the criteria; a more thorough search method to include grey literature may have improved results. The authors did not specifically state that they used the Cochrane methods selection process and it is unclear if the authors identified all relevant trials. The methods describe the process and tools used to assess the quality of the individual studies. The quality was rated on a 100 point system based on methodology of good quality a score of 50 or higher indicates good quality. All studies included scored between points. Results were fairly consistent from study to study. The researches included about validity and quality of each study. The authors addressed publication biases. 5. Did the investigators address publication bias Are the valid results of this SR important? Yes 63

64 6. Were the results homogenous from study to study? a. If not, what are the consequences for this review s results? 7. If the paper is a meta-analysis did they report the statistical results? Did they include a forest plat? What other statistics do they include? Are there CIs? 8. From the findings, is it apparent what the cumulative weight of the evidence is? The results from study to study were fairly homogenous, indicating SMT may be an effective intervention for the treatment of CGH. This was not a meta-analysis. No other statistical results were reported. The cumulative weight of the evidence suggests SMT may be an effective intervention for the treatment of CGH. Can you apply this valid, important evidence from this SR in caring for your patient/client? What is the external validity? Yes, good. 9. Is your patient different from those in this SR? 10. Is the treatment feasible in your setting? Do you have the facilities, skill set, time, 3 rd party coverage to provide this treatment? 11. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? The populations in these article resemble typical clientele that are seen in clinical settings. There was one exception in which the article used children and adolescents however there were no statistically significant results concluded from that study. The treatments offered from study to study are feasible options for a typical clinical setting. The primary skill set is manual therapy, specifically SMT. The primary consideration is the patient s preference to SMT. The interventions suggested in these study s typically fit the values and expectations for a physical therapy visit. Few patients are adverse to SMT when pain relief is the aim. What is the bottom line? Summarize your findings and relate this back to clinical significance This SR suggests that SMT, as part of a physical therapists approach to manage CGH, might be an effective treatment. However, future research must focus on frequent CGH as opposed to infrequent CGH. Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

65 Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain Jul;13(5): Level of Evidence (Oxford scale): 1a Purpose: This paper systematically reviewed randomized clinical trials assessing the efficacy of manual therapies for cervicogenic headache. Methods: The literature search was done on CINHAL, Cochrane, Medline, Ovid and PubMed. Search words were cervicogenic headache (CGH) and chiropractic, manipulative therapy, massage therapy, osteopathic treatment, physiotherapy or spinal mobilization. All RCT s written in English using either of the manual therapies on CGH were evaluated. CGH was preferentially classified according to the criteria of the IHS from 1988 or its revision from 2004, or according to the Cervicogenic Headache International Study Group. The studies had to evaluate at least one CGH outcome measure, i.e. pain intensity, frequency, or duration. The first author assessed the methodological quality of the included RCT studies. Results: One of the major problems in all the RCTs is the fact that the majority of participants had intermittent CGH. However, c CGH is often characterized by a continuous headache with an intensity that might fluctuate rather than being a paroxysmal disorder. The fact that CGH is often continuous makes sense, assuming that CGH is caused by local factors in the neck/cervical spine. Another major problem is the fact that clinical diagnostic criteria for CGH have not proved to be valid. So far there have not been conducted any RCTs on the effect of medicine in CEH. Bottom Line: Current RCT s suggest that physiotherapy and SMT might be an effective treatment in the management of CGH. However, the RCTs mostly included participants with infrequent CGH. The methodological approach to current RCT s needs to improve before definitive conclusions can be made regarding the efficacy of manual therapy for the treatment and management of CGH. 65

66 Appendix 7 Systematic Review Evidence Appraisal Worksheet Citation (use AMA or APA format): Posadzki P, Ernst E. Spinal manipulations for cervicogenic headaches: a systematic review of randomized clinical trials. Headache Jul-Aug;51(7): Level of Evidence (Oxford scale):1a Does the design follow the Cochrane method? Step 1 formulating the question Do the authors identify the focus of the review A clearly defined question should specify the types of: people (participants), interventions or exposures, outcomes that are of interest studies that are relevant to answering the question The objective of this SR was to assess the effectiveness of spinal manipulations as a treatment option for cervicogenic headaches. The primary outcome of interest was pain management. Step 2 locating studies Should identify ALL relevant literature Did they include multiple databases? Was the search strategy defined and include: o Bibliographic databases used as well as hand searching o Terms (key words and index terms) o o o Citation searching: reference lists Contact with experts to identify grey literature (body of materials that cannot be found easily through conventional channels such as publishers) Sources for grey literature Part 3:Critical Appraisal/Criteria for Inclusion Were criteria for selection specified? Did more than one author assess the relevance of each report Were decisions concerning relevance described; completed by nonexperts, or both? Did the people assessing the relevance of studies know the names of the authors, institutions, journal of The researchers performed a search from seven databases from their inception to A list of search terms was included in the methods section. Grey literature was collected via a hand search through the authors own extensive department files. No language restrictions were imposed. Criteria for selection were specified. Two independent reviewers extracted key data of the included trials according to pre-specified criteria. The same two independent reviewers estimated methodological quality using the Jadad score and the Cochrane tool. The independent reviewers were blind to the authors, institutions and journals prior to application of inclusion criteria. 66

67 publication and results when they apply the inclusion criteria? Or is it blind? Part 3 Critically appraise for bias: Selection Were the groups in the study selected differently? Random? Concealed? Performance- Did the groups in the study receive different treatment? Was there blinding? Attrition Were the groups similar at the end of the study? Account for drop outs? Detection Did the study selectively report the results? Is there missing data? Part 4 Collection of the data Was a collection data form used and is it included? Are the studies coded and is the data coding easy to follow? Were studies identified that were excluded & did they give reasons why (i.e., which criteria they failed). Selection: This study poorly described the selection process from study to study. However the authors acknowledge a relatively heterogeneous population across RCT s Performance: The authors acknowledge a relatively heterogeneous range of interventions across RCT s. Attrition: Groups were not similar at the end of the study, and the RCT s did account for dropouts. Detection: 5 of the 9 RCT s failed to report information regarding adverse effects. Collection data form was used and included in the article. The studies were coded; coding was included and easy to follow. No specific exclusion criteria were given nor justification for excluded articles. Are the results of this SR valid? 1. Is this a SR of randomized trials? Did they limit this to high quality studies at the top of the hierarchies a. If not, what types of studies were included? b. What are the potential consequences of including these studies for this review s results? 2. Did this study follow the Cochrane methods selection process and did it identify all relevant trials? a. If not, what are the consequences for this review s results? 3. Do the methods describe the processes and tools used to assess the quality of individual studies? a. If not, what are the consequences for this review s results? 4. What was the quality of the individual studies included? Were the results consistent from study to study? Did the investigators provide details about the research validity This is a SR of RCT s. Only the highest quality studies at the top of the hierarchies were used. This study followed the Cochrane methods selection process. The authors acknowledge the fact that some article may have been missed in their search process. Consequences of this are potentially missing relevant, significant data. The methods describe the processes and tools used to assess the quality of individual studies. Overall, the RCT s in this SR had mostly poor methodological quality. The results were heterogeneous from study to study. Information regarding research validity and quality of studies was 67

68 or quality of the studies included in review? included. 5. Did the investigators address publication bias Publication bias was addressed Are the valid results of this SR important? 6. Were the results homogenous from study to study? a. If not, what are the consequences for this review s results? 7. If the paper is a meta-analysis did they report the statistical results? Did they include a forest plat? What other statistics do they include? Are there CIs? 8. From the findings, is it apparent what the cumulative weight of the evidence is? Results were mostly homogenous from study to study suggesting that SMT is effective in treating CGH. However the data is not conclusive and there continues to be unanswered questions regarding adverse effects of SMT. This paper is not a mets-analysis. No. This article emphasizes the paucity of supportive evidence for SMT as a treatment option for CGH. Can you apply this valid, important evidence from this SR in caring for your patient/client? What is the external validity? 9. Is your patient different from those in this SR? This article failed to report the ages of the subjects from study to study. This makes deciding upon similarities between patient demographics difficult. 10. Is the treatment feasible in your setting? Do The treatments suggested in the RCT s appear you have the facilities, skill set, time, and 3rd feasible. However, some of the RCT s lack party coverage to provide this treatment? sufficient description to replicate treatment. 11. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? Yes. The treatments used typically fit within reasonable values and expectations. What is the bottom line? Summarize your findings and relate this back to clinical significance This article points out many important factors; primarily the lack of reported adverse reactions. While the quality methodology is poor, the RCT s are inconclusive in determining if SMT is a valid treatment option for CGH. Bottom line: SMT cannot be regarded as an evidence-based approach in the treatment of CGH. Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

69 Posadzki P, Ernst E. Spinal manipulations for cervicogenic headaches: a systematic review of randomized clinical trials. Headache Jul-Aug;51(7): Level of Evidence (Oxford scale): 1a Purpose: The purpose of this systematic review was to assess the effectiveness of spinal manipulations as a treatment option for cervicogenic headaches. Methods: Seven bibliographic databases were searched using the terms: Cervicogenic headache combined with spinal manipulative therapy, spinal manipulation, cervical manipulation, chiropractic manipulation, and osteopathic manipulation. The authors department files were also hand-searched. The abstract of the articles thus located were then screened in End Note to remove duplicates and irrelevant studies. To be included, a clinical trial had to be randomized or quasi-randomized, test the feasibility or effectiveness of SM, and focus on the treatment of CGH in human subjects. Any painrelated outcome measures were considered eligible. Any type of control intervention was admissible. Results: The results of 6 RCTs suggested that SMT is effective for treating CGH compared to physical therapy, light massage, drug therapy, or no intervention. Three RCTs showed no differences in pain, headache duration and frequency compared to placebo manipulation, physical therapy, massage, or wait list controls. Most trials had major methodological flaws. Three RCTs were of low quality and these favored SM. Three RCTs that were of high quality favored SM. One high-quality study showed no effect. Six RCTs adhered to International Headache Society diagnostic criteria or these described by Sjaastad et al. Three RCTs failed to adhere to any diagnostic criteria. Bottom Line: The evidence from RCTs of SMT for treatment of CGH is ambiguous and inconclusive. Current RCT s lack methodological consistency from study to study and fail to report critical information such as adverse events. A stringent methodological approach is needed in order to perform consistent, reliable RCT s. 69

70 Appendix 8 Systematic Review Evidence Appraisal Worksheet Citation (use AMA or APA format): Carlesso LC, Gross AR, Santaguida PL, Burnie S, Voth S, Sadi J. Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. Man Ther Oct;15(5): Level of Evidence (Oxford scale):1a Does the design follow the Cochrane method? Step 1 formulating the question Do the authors identify the focus of the review A clearly defined question should specify the types of: people (participants), interventions or exposures, outcomes that are of interest studies that are relevant to answering the question The goal of this SR was to synthesize the literature that has reported adverse events (AE) related to both cervical manipulation and mobilization techniques across professions at the highest level of evidence. Studies that are relevant to answer the question are discussed in the introduction. Step 2 locating studies Should identify ALL relevant literature Did they include multiple databases? Was the search strategy defined and include: o Bibliographic databases used as well as hand searching o Terms (key words and index terms) o o o Citation searching: reference lists Contact with experts to identify grey literature (body of materials that cannot be found easily through conventional channels such as publishers) Sources for grey literature Part 3:Critical Appraisal/Criteria for Inclusion Were criteria for selection specified? Did more than one author assess the relevance of each report Were decisions concerning relevance described; completed by nonexperts, or both? Did the people assessing the relevance of studies know the names of the authors, institutions, journal of 5 bibliographic databases and grey literature from 1998 to 2009 were searched for any AE associated with cervical manipulation. A full list of terms and specific search strategy is available from the authors upon request. Sources of grey literature were identified and contact with experts was identified in the search for grey literature. Criteria for selection were clearly stated in the methods. At least two independent reviewers were involved in all stages of the review. It is unclear if the assessors knew the names of authors, institutions, or journals when they applied inclusion criteria. 70

71 publication and results when they apply the inclusion criteria? Or is it blind? Part 3 Critically appraise for bias: Selection Were the groups in the study selected differently? Random? Concealed? Performance- Did the groups in the study receive different treatment? Was there blinding? Attrition Were the groups similar at the end of the study? Account for drop outs? Detection Did the study selectively report the results? Is there missing data? Part 4 Collection of the data Was a collection data form used and is it included? Are the studies coded and is the data coding easy to follow? Were studies identified that were excluded & did they give reasons why (i.e., which criteria they failed). Selection: The selection criteria were clearly outlined in this SR. Performance: There was a relatively homogeneous treatment between RCT s. Blinding was indicated where applicable. Attrition: Groups were similar at the end of the study and dropouts were accounted. Detection: The most notable missing data were incidence of adverse events. While some RCT s included incidence of AE, others omitted. A data collection form was used and is available from the authors by request. RCT s were assessed using the Cochrane risk of bias tool and the McHarm quality assessment. Observational studies were assessed using a modified form from the Critical Skills Appraisal Programme. The forms were not included. Excluded studies were identified and justification was given for exclusion. Are the results of this SR valid? 1. Is this a SR of randomized trials? Did they limit this to high quality studies at the top of the hierarchies a. If not, what types of studies were included? b. What are the potential consequences of including these studies for this review s results? 2. Did this study follow the Cochrane methods selection process and did it identify all relevant trials? a. If not, what are the consequences for this review s results? 3. Do the methods describe the processes and tools used to assess the quality of individual studies? a. If not, what are the consequences for this review s results? 4. What was the quality of the individual studies included? Were the results consistent from study to study? Did the investigators provide details about the research validity or quality of the studies included in review? 5. Did the investigators address publication bias Yes This is an SR of RCT s limited to high quality studies on the top of the hierarchies. This study followed the Cochrane methods selection process. They do not claim to have identified all relevant data due to various factors such as unreported studies and/or unpublished studies due to undesirable outcomes. The methods thoroughly describe the process and tools used to assess the quality of the individual studies. The quality from study to study was included. The results varied from study to study however, the major inconsistency was the reporting (or lack of reporting) of AE. Since this SR looked into AE the research validity for each RCT was not addressed, only the reporting of AE. 71

72 Are the valid results of this SR important? 6. Were the results homogenous from study to study? a. If not, what are the consequences for this review s results? 7. If the paper is a meta-analysis did they report the statistical results? Did they include a forest plat? What other statistics do they include? Are there CIs? 8. From the findings, is it apparent what the cumulative weight of the evidence is? Results were somewhat homogeneous. Studies that reported AE were grossly minor scale adverse events and no catastrophic events were recorded in any of the study s Statistical results were reported. There was a forest plot risk ratio were calculated as well as CI s There is not an apparent cumulative result from this evidence presented in this SR. However, there is no strong evidence that links the occurrence of adverse events to the treatment of SMT. Can you apply this valid, important evidence from this SR in caring for your patient/client? What is the external validity? 9. Is your patient different from those in this SR? The patients from these RCT s are representative of typical patents the are treated with SMT for CGH. 10. Is the treatment feasible in your setting? Do The studied treatment is SMT, which is a you have the facilities, skill set, time, and 3rd feasible, relatively inexpensive treatment party coverage to provide this treatment? option. 11. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? In most cases SMT does not go against patient beliefs and fits within typical expectations. What is the bottom line? Summarize your findings and relate this back to clinical significance While the findings from this SR are inconclusive, there are a few key variables to note. First, the incidence of AE in current literature regarding SMT is grossly underreported. This failure to report leads the authors to conclude that more stringent reporting of AE is required in RCT s as well as in other literature. Second, there were no Catastrophic events reported across any eligible study, however this does not exclude the possibility that minor adverse events are occurring and underreported. Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

73 Carlesso LC, Gross AR, Santaguida PL, Burnie S, Voth S, Sadi J. Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. Man Ther Oct;15(5): Level of Evidence (Oxford scale): 1a Purpose: The purpose of this SR was to synthesize the literature that has reported adverse events (AE) related to both cervical manipulation and mobilization techniques across professions at the highest level of evidence. Methods: Five bibliographic databases and the gray literature were searched from 1998 to 2009 for any AE associated with cervical manipulation or mobilization for neck pain. Randomized controlled trials prospective or cross-sectional observational studies were included. Two independent reviewers conducted study selection, method quality assessment and data abstraction. Pooled relative risks (RR) were calculated. Study quality was assessed using the Cochrane system, a modified Critical Appraisal Skills Program form and the McHarm scale to assess the reporting of harms. Results: Seventeen of 76 identified citations resulted in no major AE. Two pooled estimates for minor AE found transient neurological symptoms and increased neck pain. Forty-four studies were excluded for not reporting AE. Bottom Line: No definitive conclusions can be made due to a small number of studies, weak association, moderate study quality, and notable ascertainment bias. According to the authors, improved reporting of AE in manual therapy trials as recommended by the CONSORT statement extension on harms reporting is warranted. The most important finding of this systematic review is the identification of the need for more stringent reporting of adverse events in MT efficacy trials. 73

74 Appendix 9 Systematic Review Evidence Appraisal Worksheet Citation (use AMA or APA format): Gross A, Miller J, D'Sylva J, et al. Manipulation or mobilisation for neck pain: a Cochrane Review. Man Ther Aug;15(4): Level of Evidence (Oxford scale):1a Does the design follow the Cochrane method? Step 1 formulating the question This focused review assesses if Do the authors identify the focus of the review manipulation or mobilization improves pain, function/disability, patient A clearly defined question should specify the types of: satisfaction, quality of life (QoL), and global perceived effect (GPE) in adults people (participants), experiencing neck pain with or without interventions or exposures, cervicogenic headache or radicular findings. outcomes that are of interest studies that are relevant to answering the question Step 2 locating studies Should identify ALL relevant literature Did they include multiple databases? Was the search strategy defined and include: o Bibliographic databases used as well as hand searching o Terms (key words and index terms) o Citation searching: reference lists o Contact with experts to identify grey literature (body of materials that cannot be found easily through conventional channels such as publishers) o Sources for grey literature Part 3:Critical Appraisal/Criteria for Inclusion Were criteria for selection specified? Did more than one author assess the relevance of each report Were decisions concerning relevance described; completed The researchers included multiple bibliographic databases. Experts were also contacted and personal databases were searched to identify grey literature. Grey literature sources were listed. Any published or unpublished RCT or quasi- RCT, either full text or abstract form, was included. An appendix was included to outline search strategy, which includes terms and reference lists. At least 2 authors with expertise in medicine, physiotherapy, chiropractic, massage therapy, statistics, or clinical epidemiology independently conducted citation identification, study selection, and data extraction. The people assessing the 74

75 by non-experts, or both? Did the people assessing the relevance of studies know the names of the authors, institutions, journal of publication and results when they apply the inclusion criteria? Or is it blind? Part 3 Critically appraise for bias: Selection Were the groups in the study selected differently? Random? Concealed? Performance- Did the groups in the study receive different treatment? Was there blinding? Attrition Were the groups similar at the end of the study? Account for dropouts? Detection Did the study selectively report the results? Is there missing data? Part 4 Collection of the data Was a collection data form used and is it included? Are the studies coded and is the data coding easy to follow? Were studies identified that were excluded & did they give reasons why (i.e., which criteria they failed). relevance of the studies were blinded to authors, institutions, journals and results when inclusion criteria were applied. Selection: The groups in this study were selected differently. There were no uniform selection criteria that could be seen from study to study. Randomization was achieved for over half of the studies in this SR and 16 out of 27 failed to conceal allocation. Performance: The treatment from group to group varied slightly. From each study, the subjects received some form of SMT and/or spinal mobilization. As a whole, failure to blind patient, provider and outcomes assessors was an issue. Attrition: Groups were similar at the end of the study and the vast majority of studies accounted for dropouts. Detection: There were many questions regarding selective reporting. As a whole, the studies were indecipherably vague about selective reporting. Collection data form was used and included. The studies were coded and the coding was relatively easy to follow. Rationale was given for exclusion criteria. Are the results of this SR valid? 1. Is this a SR of randomized trials? Did they limit this to high quality studies at the top of the hierarchies a. If not, what types of studies were included? This is an SR limited to only high quality randomized trials at the top of the hierarchies. Consequences are that lower levels of evidence are not considered in the data. 75

76 b. What are the potential consequences of including these studies for this review s results? 2. Did this study follow the Cochrane methods selection process and did it identify all relevant trials? a. If not, what are the consequences for this review s results? 3. Do the methods describe the processes and tools used to assess the quality of individual studies? a. If not, what are the consequences for this review s results? 4. What was the quality of the individual studies included? Were the results consistent from study to study? Did the investigators provide details about the research validity or quality of the studies included in review? 5. Did the investigators address publication bias This was a Cochrane review; the Cochrane methods selection process was used. This study does not claim to have identified all relevant trials. Potential consequences are missing data that could further the understanding of this topic. The methods thoroughly describe the processes and tools used to assess the quality of individual studies. The individual studies were of moderate to high quality. The results varied from study to study. The investigators used the GRADE approach to detail the quality of the studies in this review. Publication bias was addressed. Are the valid results of this SR important? 6. Were the results homogenous from study to study? a. If not, what are the consequences for this review s results? 7. If the paper is a meta-analysis did they report the statistical results? Did they include a forest plat? What other statistics do they include? Are there CIs? 8. From the findings, is it apparent what the cumulative weight of the evidence is? Results were mostly heterogeneous from study to study. However, some homogenous data could be extracted from the data. Consequences of these findings are that there is still no conclusive evidence to support one treatment over another. This paper is not a meta-analysis. Forrest plots were included. For continuous data mean difference was calculated with 95%CI. For continuous outcomes reported as medians, effect size, relative risk, NNT and MCID were calculated. The cumulative weight of the evidence is that there is a lack of quality methodological procedure when it comes to quality research on the topic of SMT for 76

77 neck pain. Furthermore, research needs to improve in the reporting of adverse events associated with SMT. Can you apply this valid, important evidence from this SR in caring for your patient/client? What is the external validity? Yes 9. Is your patient different from those in this SR? 10. Is the treatment feasible in your setting? Do you have the facilities, skill set, time, and 3rd party coverage to provide this treatment? 11. Does the intervention fit within your patient/client s stated values or expectations? a. If not, what will you do now? The patient is that is being researched is similar to the majority of the patients in these study s. The treatment is feasible in a typical PT setting and is within scope of practice. The intervention fits within the patients beliefs, values and expectations. What is the bottom line? Summarize your findings and relate this back to clinical significance This SR identified implications for practice that may be used to guide treatment, they are: cervical manipulation and mobilizations provide similar pain relief, functional improvement, and patient satisfaction; cervical manipulation may provide short term but not long term pain relief; thoracic manipulation alone or in combination with electro-thermal or individualized physiotherapy treatments may improve pain and function; anteriorposterior mobilizations may be superior to transverse, oscillatory and rotational mobilizations. Adapted from : Jewell, D. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett Publishers, Sudbury, MA

78 Gross A, Miller J, D'Sylva J, et al. Manipulation or mobilisation for neck pain: a Cochrane Review. Man Ther Aug;15(4): Level of Evidence (Oxford scale): 1a Purpose: The purpose of this review was to assess if manipulation or mobilization improves pain, function/disability, patient satisfaction, quality of life and global perceived effect in adults experiencing neck pain with or without cervicogenic headache or radicular findings. Methods: A computerized search was performed in July Randomized trials investigating manipulation or mobilization for neck pain were included. Two or more authors independently selected studies, abstracted data, and assessed methodological quality. Pooled relative risk and standardized mean differences were calculated. Results: Moderate quality evidence showed cervical manipulation and mobilization produced similar effects on pain, function and patient satisfaction at intermediate-term follow-up. Low quality evidence suggested cervical manipulation might provide greater short-term pain relief than a control. Low quality evidence also supported thoracic manipulation for pain reduction and increased function in acute pain and immediate pain reduction in chronic neck pain. Bottom Line: The overall methodological quality of trials has not improved in spite of CONSORT guidelines. The evidence suggests some immediate- or short-term pain relief with a course of cervical manipulation or mobilization alone, but these benefits are not maintained over the long-term. Evidence seems to support the use of thoracic manipulation alone for immediate pain relief or as an adjunct to electro thermal or individualized physiotherapy treatment strategies for pain relief and improvements in function. One dose-response trial and one trial with a low risk of bias that used a factorial design emerged. Certain mobilization techniques may be superior however, optimal technique and dose need to be determined and better defined. 78